A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 228 in Subjects With Selected Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- AMG 228
- Conditions
- Advanced Malignancy
- Sponsor
- Amgen
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- AMG 228 maximum observed concentration (Cmax)
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity, and identify a tolerable dose of AMG 228 in subjects with advanced solid tumors.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject must have a pathologically documented, definitively diagnosed, advanced solid tumor
- •Adequate hematological, renal, hepatic, and coagulation laboratory assessments
Exclusion Criteria
- •Active autoimmune disease, history of autoimmune disease
- •Treatment with immune modulators including
- •Use of warfarin, factor Xa inhibitors, or direct thrombin inhibitors
- •Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days
- •Major surgery within 28 days of study day 1
Arms & Interventions
AMG 228 monotherapy
Part 1 and Part 2 of the study will both be with single agent AMG 228 in different selected tumor types.
Intervention: AMG 228
Outcomes
Primary Outcomes
AMG 228 maximum observed concentration (Cmax)
Time Frame: 9 months
Subject incidence of dose limiting toxicities (DLT)
Time Frame: 9 months
Subject incidence of treatment-emergent adverse events
Time Frame: 9 months
Subject incidence of treatment-related adverse events
Time Frame: 9 months
Subject incidence of clinically significant changes in vital signs and physical assessments
Time Frame: 9 months
Subject incidence of clinically significant changes in ECGs
Time Frame: 9 months
Subject incidence of clinically significant changes in clinical laboratory tests
Time Frame: 9 months
AMG 228 minimum observed concentration (Cmin)
Time Frame: 9 months
AMG 228 area under the concentration-time curve (AUC)
Time Frame: 9 months
AMG 228 half-life (t1/2)
Time Frame: 9 months
Secondary Outcomes
- Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1(9 months)
- Incidence of anti-AMG 228 antibody formation(9 months)
- Activation status and changes in numbers of T regulator cells (Treg)(9 months)
- Subject objective response per immune-related Response Criteria (irRC)(9 months)
- Activation status of cytotoxic T lymphocytes (CTL)(9 months)
- Changes in numbers of cytotoxic T lymphocytes (CTL)(9 months)